Policy Update

The first four months of 2017 have been nothing short of tumultuous in the Washington world of health care policy. As a result, the American Society of Nephrology (ASN) Policy and Advocacy Committee (PAAC) members are engaged on numerous policy fronts from efforts to repeal the Affordable Care Act (ACA) to the executive order on immigration and its travel ban to President Donald J. Trump’s budget proposal to cut funding for the National Institutes of Health (NIH) by nearly 20%.

Waiting on November elections

Opponents continue to work toward a full repeal in Congress, and presidential candidate Mitt Romney has made repealing the Affordable Care Act (ACA) one of his primary campaign points. Arizona, Kansas, Nebraska, and South Dakota continue to hold still or move slowly in anticipation of the November election.

Opting out of state exchanges and Medicaid expansion

 

The Centers for Medicare and Medicaid Services (CMS) released a proposed rule on July 2, 2012, that addresses dialysis care. The ASN Quality Metrics Task Force is analyzing the proposed rule and, with the ASN Public Policy Board, will provide input to CMS on behalf of ASN members.

The Centers for Medicare and Medicaid Services (CMS) announced final plans for modifications to the End-Stage Renal Disease (ESRD) Program. The payment related revisions set forth in its rulemaking will affect the ESRD Prospective Payment System (PPS) beginning in 2013, and quality-related changes will affect the ESRD Quality Incentive Program (QIP) in 2014, 2015, and beyond.

On March 16, 2017, President Trump released the annual White House Budget Request. Dubbed the “Skinny Budget,” the budget—while light on details—is heavy-handed in the cuts it proposes to non-defense discretionary (NDD) funding. Chief among the $54 billion worth of cuts to NDD funding is a $15.1 billion cut to the Department of Health and Human Services (HHS), roughly 18% less than the department received last year.

In September of 2016, ASN hosted its Second PhD Summit in Washington, DC, to discuss how the society can better serve PhD members. Participants outlined seven recommendations for the ASN Council to consider to achieve that goal. This February, ASN Council approved a plan to implement the Summit’s recommendations. Table 1 shows the final recommendations and the relevant ASN committee assigned to implement them.

The legislative effort to repeal the Affordable Care Act (ACA) suffered a stunning setback when the bill designed to replace the ACA, the American Health Care Act (AHCA), was withdrawn from consideration on the floor of the House of Representatives on March 24. After seven years of Republicans in Congress promising to strike the signature health care law of former President Barack Obama, this strategic legislative undoing so rapidly and publicly left many in Washington scratching their heads. How did it happen and what comes next? How it happened is becoming clearer.

In January 2017, Congress decided to use the lesser known legislative vehicle called budget reconciliation for repealing the ACA. Created by the Congressional Budget Act of 1974, budget reconciliation allows for expedited consideration of certain tax, spending, and debt limit legislation. In the Senate, reconciliation bills are not subject to filibuster and the scope of amendments is limited, giving this process real advantages for enacting controversial budget and tax measures such as ACA repeal.

The American Society of Nephrology (ASN) has repeatedly cautioned health care policymakers that kidney diseases are at staggering levels and, for decades, there have been too few new therapies for treating patients. Now, the US Government Accountability Office (GAO) has conducted a study and published its findings in a new report released January 18, 2017, National Institutes of Health: Kidney Disease Research Funding and Priority Setting, that statistically validates these points.

In late 2016, Congress passed and President Barack Obama signed into law the 21st Century Cures Act, a sweeping medical innovation bill authorizing more National Institutes of Health (NIH) funding and supporting patient perspectives in U.S. Food and Drug Administration (FDA) approvals.

With Kidney Week 2016 in review and the end of the year rapidly approaching, one New Year’s treat is already waiting for everyone. It arrived January 1, 2017, as scheduled. The New Year heralds the beginning of the new Quality Payment Program (QPP) that was created by the Medicare Access and CHIP Reauthorization Act (MACRA).

Telehealth services for home dialysis patients and care for patients with acute kidney injury (AKI) will get a boost from changes to the Physician Fee Schedule and the End-Stage Renal Disease (ERSD) Prospective Payment System (PPS) announced by the Centers for Medicare & Medicaid Services (CMS) in October and November.

Heraclitus could have been speaking about the present-day practice of medicine with his gaze focused on the future—especially in nephrology. American Society of Nephrology (ASN) President Raymond C. Harris, MD, FASN, recently underscored this thought in Kidney News Online when he wrote “how we practice currently will be very different from practice patterns 20, 10, or even 5 years from now.”

With Republican Presidential candidate Donald Trump proposing to repeal the Affordable Care Act (ACA) and Democratic candidate Hillary Clinton promising to strengthen and expand it, this year’s presidential race offers stark choices on health care reform.

On Thursday, July 7, the ASN Research Advocacy Committee participated in meetings at the U.S. National Institutes of Health (NIH) and Department of Veterans Affairs (VA) during the society’s annual Kidney Research Advocacy Day (Table 1). ASN Research Advocacy Committee Chair Frank C. Brosius, MD, and ASN Public Policy Board Chair John R. Sedor, MD, FASN, also participated in a first-ever ASN meeting with the White House Office of Management and Budget on Friday, July 8.

On June 13, 2016, ASN and the Kidney Health Initiative (KHI)—the society’s public-private partnership with the US Food and Drug Administration—participated in a summit the White House convened to address the shortage of organs available for transplantation. The White House Organ Summit brought together a wide variety of stakeholders committed to building on the Obama administration’s efforts to improve outcomes for individuals waiting for organ transplants and support for living organ donors.

Highlighting successful strategies to increase patient access to home dialysis and reduce racial disparities in home modalities, ASN Councilor Susan Quaggin, MD, FASN, of Northwestern University in Chicago, addressed a packed briefing room on Capitol Hill in May 2016.

In the coming months, the Centers for Medicare & Medicaid Services (CMS) will begin implementing a 2015 law that changes how doctors who provide care to Medicare beneficiaries are paid. ASN is working with CMS to help the Agency get the new system —which aims to reward value over volume—right for nephrology clinicians and the patients with kidney disease they serve.

Congress is not expected to accomplish much before the general election season begins in earnest this summer, but there is broad bipartisan support for accelerating the discovery, development, and delivery of promising new therapies.

ASN President Raymond C. Harris MD, FASN, (left) and Raymond M. Hakim MD, PhD, (right) meet with congressional Representative Jim Cooper (D-TN, center) in his office on Capitol Hill to discuss the Living Donor Protection Act (S. 2584/H.R. 4616).

Physicians will have more flexibility to choose quality indicators and less restrictive electronic health record requirements under a streamlined value-based payment system proposed by the Centers for Medicare & Medicaid Services (CMS) in April.

Kidney transplantation is the optimal renal replacement therapy for the majority of people with kidney failure—yet the nearly 110,000 Americans on the kidney wait list face significant barriers to receiving a transplant. The Living Donor Protection Act aims to eliminate some of these barriers and increase transplantation by strengthening and protecting the rights of living organ donors.

The Department of Veterans Affairs (VA) helps fund more than 3400 investigators around the country who conduct cutting-edge veteran-focused research in many areas, including kidney disease. More than 3000 veterans are diagnosed with kidney failure each year, and 30,000 veterans are on dialysis.

On February 9, 2016, President Barack Obama released his budget proposal for 2017, the official start of the congressional budget process. Although the proposal includes increases for the National Institutes of Health (NIH) and other ASN priorities, it relies on budget gimmicks that some congressional appropriators are calling nonstarters.

Looking back to this time last year, ASN was commending President Obama for his bold leadership in securing a budget increase for NIH and NIDDK in 2016. Regrettably, his 2017 budget proposal would short-change NIDDK and kidney research. Kidney disease affects more than 20 million Americans and costs Medicare $80 billion. The Medicare End-Stage Renal Disease Program alone costs $35 billion, more than NIH’s entire budget. Yet federal investments in kidney research are less than 1% of total kidney care costs.

Patients with kidney disease may see several positive changes to their ESRD care options in 2016. A bipartisan “Chronic Care Working Group” formed by the Senate Finance Committee recently released a white paper outlining policy changes they are interested in enacting this year—including several components related specifically to kidney care.

The new National Institutes of Health (NIH) strategic plan (Figure 1) released in December 2015 includes three ASN recommendations that will guide the agency’s research agenda over the next five years. During summer 2015, 450 stakeholders in the research community responded to NIH’s request for feedback and input.

Figure 1. 2016–2020 NIH strategic plan

Last year, the US Senate Committee on Finance (SFC) took its first step toward developing legislation that would advance higher quality care at lower cost for the millions of Americans managing chronic illness.

Not many people know about the US Department of Veterans Affairs’ (VA) research program outside the Washington beltway. The lack of recognition may in part be because the program is dwarfed by the National Institutes of Health (NIH) budget ($589 million vs. $29.4 billion in 2015). Yet the VA is a leader in a number of research fields, including vision and hearing loss, orthopedics and prosthetics, and mental health issues such as posttraumatic stress disorder and traumatic brain injury.

These are the major policy issues affecting the kidney community in 2015.

Building upon nearly a year of hearings, roundtables, and input from patient and other advocacy groups, the House Energy and Commerce Committee released a draft piece of legislation aimed at spurring the development of innovative new therapies and speeding their delivery to patients. Energy and Commerce Committee Chair Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) launched this bipartisan effort—the 21st Century Cures Initiative—during the last Congress, and the committee floated a preliminary draft bill in January 2015.

On February 2, 2015, President Barack Obama released his proposed federal budget for Fiscal Year 2016 (October 1, 2015, to September 30, 2016), the starting point of the congressional budget-making process.

In his State of the Union address, the president made the case that the US has turned the corner on the economy and is now in a stable position. As such, the president is now asking Congress to make investments in government services—including research—that have been underfunded since Congress instituted deficit reduction measures earlier in the decade.

Often compared to the health maintenance organizations (HMOs) of the past, accountable care organizations (ACOs) have taken the spotlight as a new model of health care delivery and payment under the Affordable Care Act. Mark McClellan, MD, PhD, former administrator of the Centers for Medicare & Medicaid Services and current director of the Engelberg Center for Health Care Reform, spoke about ACOs at the 2011 Kidney Week Christopher R. Blagg Endowed Lectureship in Renal Disease and Public Policy.

The Centers for Medicare and Medicaid Services (CMS) last month released its long-awaited rule finalizing changes to the End-Stage Renal Disease Program (ESRD) payment system and the Quality Incentive Program (QIP). The final rule outlined modifications to the ESRD prospective payment system (PPS) for 2012, and it cemented adjustments—as well as major additions—to the QIP program across 2013 and 2014.

Throughout its history, the government of the United States has traditionally expanded services to veterans after the outbreak of a major conflict. Whereas individual states initially carried the majority of the burden of caring for wounded soldiers, the federal government has gradually expanded its responsibility in this arena.

The U.S. Food and Drug Administration (FDA) recently recommended more conservative dosing guidelines for erythropoiesis-stimulating agents (ESAs) used to treat anemia in patients with chronic kidney disease (CKD), for both patients receiving dialysis and those not receiving dialysis. Before the FDA’s announcement on June 24, 2011, product labels for ESAs recommended dosing to achieve and maintain hemoglobin levels within the target range of 10–12 g/dL in patients with CKD.

On Friday, September 14, 2012, the White House Office of Management and Budget (OMB) released a highly anticipated report on the likely effects of sequestration (the automatic across-the-board cuts of $1.2 trillion passed as part of the Budget Control Act in 2011 that are slated to take effect beginning January 2013). The report confirmed what everyone already knew—sequestration would bring massive budget cuts that would devastate federal programs.

ASN needs your support to protect medical research funding. It’s one of the smartest investments our country can make.

Research generates jobs, stimulates the economy, and enables life-saving medical advances. If Congress doesn’t act by January 2013, federal funding for NIH will be cut by 8.2 percent, eliminating up to 2300 NIH research grants.

Promote more patient-centered care. Include patients with end stage renal disease as well as later stages of chronic kidney disease. Allow a diversity of dialysis provider sizes and types to participate.

The Centers for Medicare & Medicaid Services (CMS) released its annual set of proposed updates and additions to the Medicare End Stage Renal Disease (ESRD) program for public comment in July 2012. The ASN Quality Metrics Task Force and Public Policy Board spent the summer analyzing the proposed rule’s potential impact on patient outcomes, access, and safety, and the integrity of the patient-physician relationship.

The Supreme Court ruling making the Affordable Care Act’s intended expansion of Medicaid optional for states is gaining attention as a sleeper issue that could destabilize some of the compromises struck to gain support for the law.

“The Roberts Court actually punched a big hole in the law, potentially reducing its historic coverage expansion by as much as a third,” Jeff Goldsmith, PhD, wrote on The Health Care Blog. Goldsmith is a professor of public health sciences at the University of Virginia.

 

Kidney disease affects millions in the United States across all populations, but it is more common among minorities. African Americans, Hispanics, Pacific Islanders, and Native Americans face a disproportionately increased risk for developing kidney disease.

The ASN Council, Public Policy Board, and Board of Advisors met with legislators on Capitol Hill as part of the biannual Board of Advisors meeting on April 26, 2012. The second annual ASN Hill Day provided ASN leaders an opportunity to talk directly with lawmakers and House and Senate staff about issues of importance to ASN and the kidney care community. ASN leaders met with more than 50 congressional offices, including more than a half-dozen meetings with senators and representatives themselves, and were divided into four teams to discuss one of the following issues.

On Thursday, September 10, 2015, the American Society of Nephrology (ASN) convened Kidney Community Advocacy Day 2015. An unprecedented group of more than 100 representatives of 16 kidney patient and health professional organizations banded together to demand Congress support legislation that would increase kidney research funding and remove barriers for people considering living kidney donation (Table 1). Altogether, advocates met with over 120 congressional offices.

In spring 2015, a multiyear advocacy effort to motivate Congress to repeal and replace the dated, flawed physician payment system—known as the Sustainable Growth Rate—succeeded with passage of a new law: the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Having worked in close collaboration with other medical societies and with Congress to advance this ASN advocacy priority, the society is now focusing efforts on working in partnership with the Centers for Medicare & Medicaid Services (CMS) as the agency implements the law.

Jonathan Blum

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An expert on Medicare will deliver the Christopher R. Blagg Endowed Lectureship in Renal Disease and Public Policy. Jonathan Blum’s topic will be “Improving Standards and Quality Outcomes: The Federal Government in Action.”

The Joint Committee on Deficit Reduction, or the “super committee” is without question the most talked-about—and feared and revered—entity in Washington, DC, this fall. Tasked by the Budget Control Act of 2011 with developing a plan by November 23 to trim at least $1.2 trillion from the national debt over the next decade, the super committee’s job is daunting. However, the committee possesses no shortage of options to meet that $1.2 trillion goal: everything is “on the table” for reductions.

The next generation in electronic records management will arrive at all Centers for Medicare & Medicaid Services (CMS)–certified end stage renal disease (ESRD) dialysis clinics by February 2012, affecting facilities, clinicians, and patients. The new system, CROWNWeb, promises to streamline the data submission process for dialysis providers and provide up-to-the-minute clinical and facility information to assist nephrologists, help improve oversight, and guide patient care decisions.

Advancing the quality of care and improving patient safety are two of the most important issues for healthcare professionals and policymakers alike. Reducing preventable injuries and illnesses in hospitals is now recognized not only to be an important goal from a patient perspective but also key to slowing the rising cost of care. Meanwhile, quality improvement initiatives—both voluntary and as a component of Medicare payment programs—are proliferating.

When the Food and Drug Administration (FDA) changed the label on erythropoiesis-stimulating agents (ESAs) in July, ASN raised concerns about the modifications to the agency. FDA met with ASN this October to discuss the society’s reservations.

Extending lifetime immunosuppressive drug coverage for kidney transplant recipients is a top ASN legislative advocacy priority. On Capitol Hill, the efforts of ASN and other advocates have paved the way for Congress to again consider providing the much-needed lifetime coverage.

A Renal Week public policy symposium used current health care models to illustrate how care delivery systems can be used to provide more cohesive care to consumers.

After considerable party posturing and uncertainty, Congress passed a last-minute temporary 2-month physician payment patch on December 17, 2011. The patch averted a 27.4 percent cut on January 1 to Medicare reimbursements, triggered by the Sustainable Growth Rate, through February 2012. Lawmakers agreed to meet after their holiday recess to consider a longer-term patch, but concerns remain that they will scour Medicare for possible savings to pay for it. Meanwhile, hope remains that Congress will find a permanent solution for replacing the Sustainable Growth Rate.

Figure 1

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A newly proposed rule on conflict of interest in medical research would reduce the monetary amount that qualifies as a conflict for researchers from $10,000 to $5000. Issued by the National Institutes of Health (NIH) in May, the rule is designed to help strengthen the current rules governing conflicts of interest between researchers and industry.

The medical community recently has raised concerns about the Food and Drug Administration’s (FDA’s) use of Risk Evaluation and Mitigation Strategy (REMS) to ensure the safe use of drugs.

Since 2008, if FDA believes a drug’s risks may outweigh its benefits, or that the drug potentially poses serious risks to patients, it mandates that the manufacturer develop a REMS. FDA instituted a REMS for erythropoeisis stimulating agents (ESAs) in February 2010.

ASN President-Elect Bruce A. Molitoris, MD, FASN, and ASN Research Advocacy Committee (RAC) members (see Table 1) participated in the society’s first-ever “NIH Advocacy Day” on Wednesday, June 20. The goal of NIH Advocacy Day was to advance the profile of kidney disease research at the National Institutes of Health (NIH) beyond NIDDK and encourage other institutes to dedicate resources to studying kidney disease where relevant to their mission.

ASN Research Advocacy Committee Chair John Sedor, MD, discusses the positive connection between research and the US economy.

A proposal to cut the End-Stage Renal Disease (ESRD) Program by nearly 10 percent may have unintended consequences for people on dialysis. This was ASN’s key message to the Centers for Medicare & Medicaid Services (CMS) in comments on the proposed rule regarding the Medicare ESRD Prospective Payment System (PPS) and Quality Incentive Program (QIP).

The deadline for nephrologists and dialysis facilities to apply to become an ESRD Seamless Care Organization (ESCO)—the first-ever disease-specific Medicare Shared Savings Program—has come and gone. As of press time, it appears that the Centers for Medicare and Medicaid Services (CMS) received fewer applications than the agency and the community had once hoped.

Despite shrinking funding for kidney research and a record low grant application success rate at the National Institutes of Health (NIH), more cuts are set to take effect in 2014 unless Congress takes action to prevent them.

On December 18, 2015, Congress passed a budget deal that averted a government shutdown and makes substantial new investments in federal research, a top ASN policy priority. The deal increased the budgets for the National Institutes of Health (NIH), including the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Department of Veterans Affairs (VA) Research Program.

Since the ASN Research Advocacy Committee began Kidney Research Advocacy Day in 2012, the committee’s annual visits to the National Institutes of Health (NIH) have helped to raise awareness about the burden of kidney disease and to build support for more investments in kidney research. When the committee returns to NIH in June, it will present specific recommendations of areas for kidney research that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) should prioritize.

A legislative capstone of 2015 was passage by the US House of Representatives of the 21st Century Cures Act, an ambitious bill aimed at accelerating the development and delivery of new therapies to patients. The Senate is working on introducing a corollary piece of legislation known as “Innovating for Healthier Americans.” Although the Senate version is not likely to be an exact mirror of the House version, the overarching goals will remain similar.

Care for people with chronic conditions accounts for 93% of all Medicare spending, and the US healthcare system’s fractured approach to care delivery does not effectively reward providers who provide the type of coordinated care these patients need. Sen. Johnny Isakson (R-GA) and Sen. Mark Warner (D-VA) convened a Chronic Conditions Working Group in 2015 to address this issue.

Implementation of a new law that entirely overhauls how Medicare pays physicians will be a major focus for ASN and the entire medical community in 2016. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) shifts physician reimbursement away from a fee-for-service system—paying for quantity of care—toward a value-based system that pays for quality of care.

A top legislative priority for ASN in 2016, the bipartisan Living Donor Act will help increase access to kidney transplants by:

In 2015, President Obama signed into law the Trade Preferences Extension Act. This law would allow dialysis-requiring Acute Kidney Injury (AKI) patients to receive treatment at a Medicare-certified End Stage Renal Disease (ESRD) facility. Currently, these patients face limited options for treatment, each of which comes with major challenges.

As part of ASN’s goal of increasing congressional support for its policy priorities, the society will launch a new Ambassador Program this year. Starting with three or four ASN members appointed by the ASN Public Policy Board, the Ambassadors will work with their congressional districts and congressional representatives to raise awareness about kidney disease in their home districts and advance ASN’s policy priorities in Congress.

On September 10, 2015, more than 100 kidney patients and health professional advocates gathered in Washington, DC, for Kidney Community Advocacy Day (KCAD). Since 2010, ASN has organized an annual congressional advocacy day to raise awareness about kidney disease. This year, representatives from 16 organizations met with more than 120 congressional offices to promote kidney research funding and increase awareness of, and support legislation to encourage, living kidney donation (Table 1).

Owing to federal austerity measures Congress implemented starting in 2011, federal spending for non-defense discretionary (NDD) programs—ranging from medical research to public health, to natural resources and veterans services—is at the lowest level since the 1950s as a percent of GDP. These measures set caps on spending for both defense and non-defense discretionary spending programs through 2021. As a result, the National Institutes of Health (NIH) has lost nearly 25 percent of its purchasing power since 2003.

The National Kidney Foundation’s “End the Wait” campaign, launched earlier this year, is an ambitious agenda aimed at improving access to kidney transplants. The campaign reflects an increasing recognition nationally that kidney transplantation is the treatment of choice for most individuals with end stage renal disease (ESRD) and a growing awareness of the imbalance between available organs and the number of patients on the waiting list.

States this year will struggle to implement some of the provisions of the Accountable Care Act (ACA) while at the same time keeping an eye on efforts to repeal several of the provisions. Major reforms are set to roll out in 2014.

Throughout 2012, the nephrology community will be focused on how Medicare’s new Quality Incentive Program (QIP) affects patient outcomes and practice patterns.

Mandated by the Medicare Improvement for Patients and Providers Act of 2008, the QIP is the only mandatory “pay-for-performance” program in Medicare. The QIP was designed to establish performance standards for dialysis facilities and to adjust payments based on meeting (or not meeting) those standards.

Recognizing the value to a comprehensive, detailed electronic database regarding all causes of death nationwide, the Centers for Disease Control and Prevention (CDC) recently initiated development of an electronic death certificate that will eventually be used nationwide. The CDC is currently pilot testing the program.

Measuring quality. Comparing effectiveness. Both will be at the fore of nephrology talk this year.

Over $1 billion in funding was appropriated for comparative effectiveness research (CER) through 2009’s American Reinvestment and Recovery Act. Research priorities set by the Institute of Medicine declared racial and ethnic health disparities—a prominent issue for nephrology—high on the list. The category “genitourinary systems” was near the bottom of the list, but project areas for grant funding include comparisons of dialysis modalities.

What were the biggest changes from the proposed rule that CMS made to the final ACO rule?

Having access to nationally representative data for one routine lab test—creatinine levels—could help researchers better understand and slow the progression of kidney disease that affects up to 26 million Americans. Recently, ASN urged the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics to add patients’ serum creatinine levels to the list of laboratory data the center collects in the National Ambulatory Medical Care Survey (NAMCS).

While the nation awaits a ruling this month from the Supreme Court on the constitutionality of the Affordable Care Act (ACA), activities working toward implementation—or lack thereof—continue to be a complicated issue for states, especially those wrestling with differing views on health reform among state policymakers, governors, insurance commissioners, and attorneys general. Many states continue to move forward with implementation even as their governors decline or return federal funding to assist in development (Table 1).

On April 26, 2012, the ASN Public Policy Board, Council, and Board of Advisors ascended Capitol Hill to participate in the second annual ASN Hill Day. ASN leaders and staff met with nearly 60 congressional offices in both the House and Senate to address four key issues of importance to ASN’s members and the patients they treat.

While the National Institutes of Health (NIH) is still sorting out how to divvy up its funding for fiscal year (FY) 2012, Congress is knee deep in the budget process for FY 2013. In February, the Obama administration released the president’s budget for 2013. It includes $71.7 billion for the U.S. Department of Health and Human Services (HHS), an 8.5 percent cut from FY 2012. To put that number in perspective, in 2010, HHS’s budget was $84.4 billion.

Although the year is only half over, as of July, 41 states will have ended their legislative sessions for the year. Of this group, 17 states will carry over bills to the 2010 session if they have already passed both the House and the Senate. Dealing with budget shortfalls and a crumbling economy continues to take up a large chunk of political time, but policy initiatives related to kidney disease and nephrology were still introduced, and some were successful in their passage.

On Halloween Eve 2014, CMS released the 2015 Physician Fee Schedule final rule, finalizing several important victories for ASN and other advocates in the kidney community.

In many ways, kidney disease is the poster child for health disparities in the United States. In 2012, African Americans were nearly four times as likely and Native Americans nearly twice as likely as whites to experience kidney failure (1). African Americans, Hispanics, Native Americans, and Alaska Natives are twice as likely as whites to have diabetes, the leading cause of kidney disease. The incidence of ESRD in people with diabetes is six times as high in Native Americans compared with the incidence in the general population of diabetes patients.

On Friday, October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) released its 2015 End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Incentive Program (QIP) final rule for calendar years 2017 and 2018. This article provides a basic overview of the key takeaways of the rule.

On September 19, 2014, ASN Secretary-Treasurer and Research Advocacy Committee Chair John R. Sedor, MD, FASN, joined other members of the committee and several of the society’s advisory groups to visit the National Institutes of Health (NIH) and Patient-Centered Outcomes Research Institute (PCORI) for “Kidney Research Advocacy Day.”

On May 1, 2014, kidney patient and health professional advocates gathered in Washington, DC, for Kidney Community Advocacy Day. Since 2010, ASN has organized an annual congressional advocacy day to raise awareness about kidney disease and promote issues important to the kidney community.

On Wednesday, April 9, ASN President Sharon M. Moe, MD, FASN, testified before the House Science, Space, and Technology Committee’s Subcommittee on Research and Technology about the long overdue need for more innovation in kidney care.

Dr. Moe voiced support for federal prize competitions as a mechanism to spur scientific and technological breakthroughs to improve kidney care and keep people off of dialysis, which, Dr. Moe testified, could result in significant savings to Medicare.

At the tail end of one of the least productive years in congressional history, Congress managed to pass a bipartisan budget deal for 2014 that President Barack Obama signed into law on January 17. The deal capped a long year of budget showdowns, including the 16-day government shutdown in October. Like most federal budgets, there is both good and bad news: the deal reinstated some funding—but not all—to budget cuts in 2014.

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On January 6, 2014, the Centers for Medicare & Medicaid Services (CMS) Medicare Program proposed excluding immunosuppressive drugs from the six protected drug classes covered under Medicare Part D plans.

Once again, Congress must address the sustainable growth rate (SGR) formula. The current law mandates an approximately 24 percent reduction to Medicare physician reimbursement for 2014. Each year Congress has prevented most of these pay cuts from taking effect. Although Congress has long recognized SGR’s flaws, it has been unable to fund a permanent fix.

ASN partnered with the Food and Drug Administration in September 2012 to form the Kidney Health Initiative (KHI), which aims to work with organizations in the kidney health arena to foster innovation and ensure patient safety.

KHI is now pleased to announce the initiative’s 65 Pioneer Members. This category of membership (Pioneer) was established to highlight the initial support of patient groups, professional organizations, industry partners, and research institutions based on their enrollment by December 31, 2013.

To meet the ever-growing need for cost savings in the Medicare part D system, the Centers for Medicare & Medicaid Services (CMS) developed the first-ever disease-specific Accountable Care Organization (ACO) for dialysis providers. Designed to reduce duplicative services and expenditures, the ACO—which CMS titled the ESRD Seamless Care Organization (ESCO) program—would consolidate all aspects of care for patients with end stage renal disease (ESRD).

Starting in 2014, physicians will have to meet new maintenance of certification (MOC) requirements designed to continually assess their knowledge base and performance. The American Board of Internal Medicine (ABIM) has expanded the conditions for MOC to include ongoing medical education activities and a patient safety requirement, and will report whether board-certified physicians are meeting MOC requirements.

The kidney community enters 2014 on the heels of receiving some good news—and some bad news—regarding dialysis payments in the Medicare ESRD program.

Congressional action on a budget deal in the final days of 2013 means that things are looking up somewhat heading into 2014. On December 10, 2013, U.S. House and Senate budget negotiators reached a deal that may reverse some federal budget cuts in 2014 and 2015. The deal raises budget caps that were established by Congress as part of its deficit reduction efforts in the Budget Control Act of 2011 (Table 1).

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On Friday, November 22, 2013, the Centers for Medicare and Medicaid Services (CMS) released a rule finalizing changes to the Medicare End-Stage Renal Disease (ESRD) Program, including a 12% cut to dialysis payments, which will be phased in over 3 to 4 years. There will be no changes to current reimbursement levels in 2014 and 2015.

ASN needs your help. Funding cuts to the National Institutes of Health (NIH) are jeopardizing kidney research. Please join ASN’s fall grassroots advocacy campaign and meet with your local congressional offices between now and January 15 to urge your U.S. representative and senators to protect patients’ chance of a cure.

These days, it seems that Congress lurches from one fiscal crisis to the next with another one set for this fall. The clock for passing a budget for Fiscal Year 2014, which begins on October 1, is quickly running out. If Congress fails to pass a budget or appropriations funding government services beyond that date, non-essential federal offices will be closed and non-essential employees furloughed.

Legislation to end a 1980s-era federal ban on the transplantation of organs from deceased HIV+ donors to patients with HIV is moving forward in Congress. At a time when reaching across the aisle is rare, the overwhelming bipartisan support for the HIV Organ Policy Equity Act (HOPE Act) and its rapid advancement in the House and Senate underscore the importance of this legislation.

Bringing ASN’s perspectives on key issues and programs affecting patients with kidney disease, ASN President Bruce A. Molitoris, MD, FASN, and ASN Public Policy Board chair Thomas H. Hostetter met with top leaders at the Centers for Medicare and Medicaid Services (CMS) in June.

ASN President Bruce A. Molitoris, MD, FASN, President-Elect Sharon M. Moe, MD, FASN, Councilor Raymond C. Harris, MD, FASN, and Research Advocacy Committee members in June visited with National Institutes of Health (NIH) leaders and staff for “Kidney Research Advocacy Day.”

It’s not every day that the House, Senate, and Congressional Budget Office (CBO) agree on something, but all three concur that the sustainable growth rate (SGR) has to go. In an attempt to control Medicare spending on physicians’ fees, Congress enacted the SGR formula in 1997. Although it has called for dramatic reductions in payments over the past decade, each year Congress has temporarily overridden the cuts and kept the SGR in place.

A recent proposal from the Centers for Medicare and Medicaid Services (CMS) to reduce the End Stage Renal Disease (ESRD) program bundle by 12 percent has generated concern throughout the kidney community. The July 1 proposed rule recommends several other changes to the ESRD Prospective Payment System (PPS) and Quality Incentive Program (QIP) but the focus and concern from ASN—as well as other health professional organizations, patient groups, dialysis providers, and industry—remains the significant proposed payment reduction.

Newly enacted legislation has changed requirements for compliance with the Health Insurance Portability and Accountability Act (HIPAA). The new provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act strengthen security measures for Protected Health Information (PHI) and step up auditing and enforcement.

Although the law took effect March 26, physicians and other covered entities have until September 23, 2013, to comply with the new, wide-ranging regulations. The provisions are outlined in the Omnibus Final Rule.

President Barack Obama released his budget request for fiscal year 2014 on April 10, 2013. In a departure from his grand and ambitious budget proposals of the past, the president made some significant concessions to meet congressional Republicans halfway.

On Wednesday, March 20, 2013, ASN and the American Society of Pediatric Nephrology (ASPN) hosted a reception on Capitol Hill to launch the activities of the Congressional Kidney Caucus in the 113th Congress. Co-chaired by Rep. Tom Marino (R-PA) and Rep. Jim McDermott (D-WA), the bipartisan Congressional Kidney Caucus was founded by Rep. McDermott and former Representative, now Senator, Mark Kirk (R-IL) in March 2002 to raise awareness in Congress about the prevalence and burden of kidney disease and advance kidney patient health.

Continuing an annual tradition, ASN leaders went to Capitol Hill for Kidney Health Advocacy Day on April 25, 2013. In a first for ASN, society leaders teamed up with patient advocates from the American Association of Kidney Patients (AAKP) and Dialysis Patient Citizens (DPC) for meetings with congressional offices in the House and Senate about issues of importance to ASN and the kidney care community. ASN, AAKP, and DPC met with more than 40 congressional offices, and met personally with members of Congress in one of every four meetings.

ASN and FDA launched the Kidney Health Initiative (KHI), a new public-private partnership in September 2012. In less than one year, KHI has made significant progress moving the partnership forward.

The Senate in June passed a bill that would reverse a decades-old ban and allow research on organ donations from HIV-positive individuals.

The bill (S 330) could pave the way for organs from HIV-positive donors to be transplanted into patients who are also HIV-positive and ultimately free up organs for other individuals. Sen. Barbara Boxer (D-Calif.) introduced the HIV Organ Policy Equity (HOPE) Act in February. A related House bill (HR 698) awaits committee action.

Advocating for passage of the Comprehensive Lifetime Immunosuppressive Drug Coverage Bill—in collaboration with the transplant and kidney communities (particularly the American Society of Transplantation)—is one of ASN’s top public policy priorities this year.

On April 25, 2013, the American Society of Nephrology (ASN) met with nearly 60 congressional offices for Kidney Health Advocacy Day. In a first for ASN, the society partnered with the American Association of Kidney Patients (AAKP) and Dialysis Patient Citizens (DPC) to build support for the following three key issues of mutual importance to the three organizations.

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KN:

You have been in your post at NIA for 5 years. How have the institute’s priorities changed over those years?

Bernard:

CMS recently relented on its requirement that ESRD programs applying to form ESRD Seamless Care Organizations (ESCOs) must have at least 500 matched beneficiaries. Applicants must now have 350 matched beneficiaries, and the deadline to submit a formal application has been pushed back to July 1, 2013.

The Department of Veterans Affairs (VA) kicked off National VA Research Week—May 13–17, 2013—with a briefing at the Washington, DC, VA Medical Center. VA Research Week celebrates the contributions of VA researchers to high quality care for veterans and medical progress. This year’s theme was “VA Research Inspires”.

Congress missed the March 1, 2013, deadline for replacing the $1.2 trillion in federal budget cuts (sequestration) mandated by the Budget Control Act of 2011. As a consequence, federal defense and domestic programs, including the National Institutes of Health (NIH), are facing an across-the-board cut—or “sequester”—of $85 billion in Fiscal Year (FY) 2013. This translates to an approximately 9 percent budget cut for the NIH and other “nonexempt nondefense programs” (nonexempt defense programs will see a cut of approximately 13 percent).

With a budget of $1.95 billion last year, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the largest source of federal funding for kidney research, but certainly not the only one. The U.S. Department of Veterans Affairs (VA) has a comprehensive research portfolio aimed at advancing the treatment of kidney failure, as well as preventing and slowing the progression of kidney disease.

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The government agency charged with developing new health care payment and service delivery models—CMS and its Center for Medicare and Medicaid Innovation (CMMI)—recently announced the Comprehensive ESRD Care Initiative.

Acute kidney injury (AKI) is a serious and growing public health problem that is encountered in the hospital setting. AKI is associated with a higher short-term risk of in-hospital death, and AKI-associated costs have been estimated at $10 billion annually in the United States, due in part to extended hospital length of stays and use of renal replacement therapies. Survivors of episodes of AKI remain at increased risk of development and progression of chronic kidney disease, end stage kidney failure, and death.

The recently released Government Accountability Office (GAO) report, “End-Stage Renal Disease: Reduction in Drug Utilization Suggests Bundled Payment is Too High,” has generated controversy within the kidney community.

Focused on erythropoiesis-stimulating agent (ESA) utilization, the report comes at a time when a potential rebasing of the bundled payment rate is already creating uncertainty and concern. The report introduces additional controversy by recommending reducing that payment rate quickly and dramatically.

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Current federal deficit reduction efforts could lead to more cuts to U.S. medical research funding. Since the November 2012 election, Congress has been consumed with averting the “fiscal cliff” on January 2, 2013.

In 2012, the Agency for Healthcare Research and Quality (AHRQ) comprehensively summarized the available evidence evaluating the risks and benefits of screening for chronic kidney disease (CKD) in the general population. Utilizing these data, the U.S. Preventive Services Task Force (USPSTF) determined that existing evidence was insufficient to balance the benefits and harms of routine screening for CKD in asymptomatic adults.

The clock is running out for the US Congress to pass a federal budget for 2016 before the new fiscal year begins on October 1. Confidence is low that Congress will meet the deadline. Many in Washington predict Congress will keep funding the government at last year’s funding levels until it can pass a full-year budget. But if Congress fails to achieve either a new budget for 2016 or agreement to keep government operating at 2015 funding levels, essential government services will shut down.

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It’s clear that patient–provider communications in the United States have not kept up with the rapid evolution in technology. Young kids are communicating with tablets and other devices that put current telehealth iterations to shame. But if we already have the technology, what is the holdup?

Since the National Institutes of Health (NIH) budget doubled between 1998 and 2003, advocates for medical research have faced an uphill battle maintaining federal support for innovative, life-saving research. Congress failed to increase NIH funding for the past five years, leading to a 15 percent net decline in funding once inflation is considered. Success rates—the percentage of reviewed grants that receive funding in a given year—plummeted from a historic 30 percent norm to approximately 20 percent in fiscal year (FY) 2008.

Did you know that you may be listed as a urologist or an internist when you bill for Medicaid? Looking at Medicaid provider enrollment applications in 48 states (two do not have accessible applications), only 20 states have unique specialty codes for nephrology. Among these, only six have unique provider codes for pediatric nephrology.

Clinical Performance Measures

The growing tide of new metrics for evaluating delivery of care for chronic kidney disease (CKD) and other outpatient services warrants a healthy look at their efficacy, according to speakers at the policy sessions at Renal Week. Even as physicians and other care providers gear up to meet the new requirements, they must also take part in evaluating how well the measures work, speakers said.

The ICD-10 billing code system for Medicare and Medicaid programs, though delayed, is on its way. Designed to replace the 27-year-old ICD-9 system, ICD-10 will expand the number of codes available for billing. With every innovation, however, comes a price tag.

Many medical groups, including the American Medical Association, American College of Physicians, and the Medical Group Management Association, solicited Nachimson Advisors to study the impact of ICD-10 coding and asked for an extended deadline for implementation, which currently stands at Oct. 1, 2011.

Since 2007, physicians and other eligible health professionals have been eligible to receive bonus Medicare payments for voluntarily reporting data to the Physician Quality Reporting System (PQRS) program. Starting in 2013, that program will no longer be voluntary, and every physician and other health professional with a National Provider Identifier (NPI) number should be aware of important changes to the PQRS that will affect their Medicare payments (Table 1).

As the clock winds down to the start of Fiscal Year 2013 on October 1, 2012, congressional leaders have reached an agreement to keep the government funded for an additional 6 months. The deal would avoid a last minute showdown over the budget and a possible government shutdown before the November election. Congress is expected to pass the continuing resolution this month, which would provide government funding through March 2013 at the levels Congress agreed to when it passed the 2011 Budget Control Act.

On April 23, the ASN Public Policy Board and Board of Advisors joined patient advocates from the American Association of Kidney Patients (AAKP) for Kidney Health Advocacy Day 2015. Participants divided into teams of three or four and met with nearly 70 congressional offices to discuss two legislative priorities that would improve kidney care and patient health: 21st Century Cures and the Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 (H.R.1130/S.598).

In an historic, overwhelmingly bipartisan vote on April 14, 2015, the U.S. Senate passed legislation to permanently replace the flawed Sustainable Growth Rate (SGR) system. President Obama signed the bill—H.R. 2, the Medicare Access and CHIP Reauthorization Act of 2015—into law shortly thereafter, ending years of uncertainty for physicians and patients participating in the Medicare system and finally putting this longstanding legislative goal to rest.

ASN President Jonathan Himmelfarb, MD, FASN (second from left), and ASN Dialysis Advisory Group chair, Rajnish Mehrotra, MD, FASN (third from left), discuss the CKD Improvement in Research and Treatment Act of 2015 in the office of their congressional representative Jim McDermott, MD (D-WA), together with ASN Executive Director Tod Ibrahim

The US Senate Finance Committee in June launched an ambitious new bipartisan working group that aims to improve the care of Medicare patients with chronic diseases. Concerned that treatment of chronic illnesses—such as kidney disease, heart disease, and diabetes—constitutes 93% of the total Medicare budget, Chairman Orrin Hatch (R-UT) and Ranking Member Ron Wyden (D-OR) heard testimony in May from Centers for Medicare & Medicaid Services (CMS) Chief Medical Officer Patrick Conway, MD, and MedPAC Commissioner Mark E.

On June 23, 2015, ASN co-sponsored a Friends of NIDDK congressional reception in Washington, DC, to formally launch the new advocacy coalition. Senate Diabetes Caucus Co-Chair Jeanne Shaheen (D-NH) and Senate Minority Whip Richard Durbin (D-IL) spoke at the reception, which also featured National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Director Griffin P. Rodgers, MD.

A new proposed rule from the Centers for Medicare & Medicaid Services (CMS) lays out changes to how Medicare will reimburse providers for dialysis care, as well as how it will assess the quality of dialysis care. Released on Friday, June 26, and open for comment from stakeholders through Tuesday, August 25, the proposal includes several anticipated adjustments to the bundled payment and modest tweaks to the Quality Incentive Program (QIP).

On April 1, 2013, the U.S. Food and Drug Administration (FDA) released its proposed rule for revision of nutrition and supplement labels (FDA 21 CFR Part 101).

Increasing kidney research. Improving our understanding of kidney failure in minority populations. Expanding access to kidney disease education. Addressing the nephrology workforce crisis. These important goals, and many other patient care and research objectives, are addressed in a new kidney bill that ASN strongly supports.

ASN Responds to Medicare’s Proposed ESRD Program Changes

Every year the Centers for Medicare & Medicaid Services (CMS) releases its proposed rule for the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and Quality Incentive Program (QIP). The American Society of Nephrology (ASN) Quality Metrics Task Force and Public Policy Board thoroughly assessed the proposed rule for potential effects on patient care and access to dialysis treatment before ASN submitted feedback to CMS.

Patients can continue to access both end-of-life care in a hospice and receive dialysis care simultaneously, declared an August 6, 2014, ruling from the Centers for Medicare and Medicaid Services (CMS). ASN, led by the ASN Geriatric Nephrology Advisory Group (GNAG) and ASN Public Policy Board, had raised concerns to Medicare regarding its June proposal that could have inadvertently forced patients who are on dialysis and who want to enter hospice for another terminal illness and continue dialysis while they die to make a choice between the two services.

For 4 years running—since 2010—Congress has implemented significant cuts to federal programs in an effort to reduce the deficit. The Budget Control Act of 2011 imposed federal budget cuts in 2012 and 2013, and set caps that will limit spending from 2014 to 2021 to rein in the deficit. As a result, funding for NIH is down nearly 4 percent from 2010. That may not sound like much, but 4% of a $30 billion annual budget is roughly $1.2 billion, more than twice the 2013 NIH budget for kidney research of $591 million.

The widening gulf between available deceased donor organs and individuals needing a transplant is no secret, nor is the lengthy wait for a deceased donor kidney. According to the United Network for Organ Sharing, as of August 15, 2014, more than 123,375 Americans are waiting for a transplant, the vast majority for a kidney (101,124). Living kidney donation can potentially provide patients with faster access to a life-saving organ than if they waited for a deceased donor kidney. In most cases, living donor kidneys offer superior clinical outcomes and overall quality of life.

The dust is still settling from the election of November 4, 2014, when Republicans gained control of both chambers of Congress. Whether a Republican Congress and a Democratic administration can work together to address the many domestic and foreign challenges confronting the country today is one of the biggest questions as we head into 2015.

On Thursday, April 21, ASN, AAKP, and kidney patients joined forces on Capitol Hill to promote the Living Donor Protection Act. 

ASN provides input on potential options for a bill to improve care for people with chronic conditions. 

Recognizing the challenges of navigating the complex maze of steps necessary to obtain approval to conduct patient-oriented research in dialysis units, the ASN Dialysis Advisory Group (DAG) created a new online resource for researchers. The “ASN Investigator Resource Center” is a clearinghouse for forms and policies regarding the research application process in national dialysis chains. Intended to be a “one-stop shopping” resource, the webpage contains all the information a researcher would need to initiate and complete the approval process.

Representative David Jolly of Florida meets to discuss the Living Donor Protection Act with Kidney Health Advocacy Day volunteers from ASN and AAKP.

ASNAAKP and kidney patients visited Capitol Hill to talk to legislators and staff about the Living Donor Protection Act. What happened?